CMS Requirements of Participation Phase 3 and Appendix PP Guidance Revision: New Emphasis on Existing Concerns

      Simply stating the obvious, the COVID-19 pandemic exposed areas of weakness in the systems we need to provide care for those in our charge. Earlier this year, the Biden-Harris Administration published its goals to improve care in a Fact Sheet (“Protecting Seniors by Improving Safety and Quality of Care in the Nation’s Nursing Homes,” Feb. 28, 2022,; yet again we were put on notice to step up and do better. We providers see this as an opportunity to improve and innovate. When medical directors meet with their facility administrators, corporate officers, and facility owners, they hear one message: provide better oversight of the medical care we give our residents.
      In response to the White House, and without changing the regulations, the Centers for Medicare & Medicaid Services revised the Requirements of Participation at Phase 3, in the Appendix PP, Guidance to Surveyors (“Revised Long-Term Care Surveyor Guidance,” June 19, 2022, There are more than 15 areas of concern being addressed (Table 1). Directly or indirectly, many of these revisions will influence how the medical team interacts with facility leadership and other clinicians to improve the quality of life and the level of services provided to our residents.
      Medical directors can be assured that pharmacists will be focusing on “Pharmacy Services,” including:
      • 1.
        The “core-four” primary categories of psychotropics (antipsychotics, antianxiety, antidepressants, and hypnotics) and gradual dose reduction.
      • 2.
        The use of medications “off label” and the supporting documentation in the medical record when they are prescribed as substitutes for psychotropics.
      • 3.
        The accuracy of diagnoses for medication orders.
      • 4.
        The misdiagnosis of schizophrenia.
      Also, in the pandemic era a logical initiative area includes redoubling efforts around infection control, the infection preventionist, appropriate staffing requirements, education, and surveillance over the use of antibiotics and their potential citation as unnecessary drugs.

      Pharmacist Interventions: Unnecessary Drug and Psychotropic Drug Tags F757, F758; Infection Control and Antibiotic Use F881

      Psychotropic monitoring and assessment for gradual dose reduction are still a high priority. Guidance now addresses the use of drugs prescribed “off label” to treat behaviors; surveyors are instructed to examine the documentation in the medical record. Examples of drugs that are not in the “core-four” categories are included and described as “medications which affect brain activity including antihistamines, anticholinergic medications, and central nervous system agents used to treat conditions such as seizures, mood disorders, pseudobulbar affect, and muscle spasms or stiffness” (see the section “Psychotropic Medications and Antipsychotic Medications (F758 Only Guidance)”).
      Valproic acid is the drug emphasized in the guidance as a notable example of this practice. We are aware that this and other examples such as gabapentin are prescribed to address agitation, behaviors, or distress. The expectation is not that these drugs will not be used but that the pharmacist, medical team, and facility will consistently apply the standards for gradual dose reduction as provided with the psychotropic medication requirements under §483.45(e).
      Antibiotics and “instances of prescribing antibiotics unnecessarily” should be cited at §483.45(d), F757. The [surveyors’] findings may support citing F881 [infection preventionist and control program, Antibiotic Stewardship Program] as well, in which case the surveyor must also show that the facility is not implementing part or all of the Antibiotic Stewardship Program (e.g., antibiotic use protocols that utilize an infection assessment tool, monitoring of antibiotic use, or feedback and education to prescribing providers)” (see section the “Key Elements of Noncompliance”).

      Where Revisions Can Be Impactful: Behavioral Health, Pain Management, Substance Use Disorders

      Facilities can be expected to see an increased scrutiny on “Behavioral Health Services” (F740). The guidance added definitions of common medical conditions including depression, anxiety, anxiety disorders, schizophrenia, and bipolar disorder.
      Pain management and the opioid crisis have received new emphasis (F697), especially with regards to pain assessment, monitoring for adverse effects, and risks around opioid prescribing. Providers should be aware of the current clinical practice guidelines to treat the distinct types of pain (acute, subacute, chronic, end of life, hospice care, cancer) and what role the use of opioids plays with regards to opioid addiction. Also, providers should become familiar with the definitions of MAT (Medication Assisted Treatment) and OUD (Opioid Use Disorder). In addition, the guidance
      • Discusses types of pain and risks for opioid addiction.
      • Educates about the concomitant use of opioids and benzodiazepines while acknowledging the use of this combination for end-of-life, palliative, or hospice care.
      • Recommends several resources for best practices material.
      Finally, the guidance provides an extensive list of potential side effects from opioids, which include those from the 2016 CDC Pain Guidelines (MMWR Recomm Rep 2016;65:1–49), and provides precautions for facility monitoring: “tolerance, meaning more medication may be needed to achieve the same level of pain relief; physical dependence which causes symptoms of withdrawal when opioid medication is stopped, or a dose is held or missed; increased sensitivity to pain; constipation; nausea, vomiting, and dry mouth; sleepiness, dizziness, and/or confusion; depression; and itching and sweating.” If the facility is not monitoring, it could be cited at the F757 Unnecessary Drug, General tag.
      Addressing the risk of and treatment options for opioid overdose is now a significant concern; the guidance states, “According to the Substance Abuse and Mental Health Administration (SAMHSA), opioid overdose deaths can be prevented by administering naloxone, a medication approved by the Food and Drug Administration to reverse the effects of opioids. The United States Surgeon General has recommended that naloxone be kept on hand where there is a risk for an opioid overdose. Facilities should have a written policy to address opioid overdoses” (see the section “Guidance § 483.25(k)”). Medical directors, consultant pharmacists, and directors of nursing should collaborate in creating or reviewing the facility policy and protocol for opioid overdoses.
      Overdose prevention is addressed in several places:
      • F563 Right to Receive/Deny Visitors — denying access to visitors who have a history of bringing illegal substances into the facility. The expectation is that staff will observe and be educated on the signs and symptoms of possible substance use after interactions with visitors or a resident’s return from a leave of absence.
      • F689 Accidents — preventing possible accidental overdoses or exposure.
      • F740 Behavioral Health Services — including how residents interact with visitors. Education for the general and direct care staff should include how to identify the signs, symptoms, and possible triggers of overdose. The security challenges include obtaining consent to inspect residents’ persons, rooms, and belongings. Of note, a facility’s staff are not expected to function as law enforcement personnel but rather refer incidents to local law enforcement officials for further action.
      Nonpharmacological interventions (F741) are to be included as opportunities for alternatives, where medically appropriate. The medical staff should become familiar with the various programs offered by facility therapeutic enrichment or activities services. The regulation on accidents (F689) addresses residents with drug-seeking behaviors and the risks associated with those who wander or attempt to leave the facility.
      Robert Accetta is a consultant pharmacist, educator, and the president/owner of Rivercare Consulting, LLC, a care strategy and consulting business for PALTC organizations.
      Table 1. Sections of the Regulations That Contain New Guidance
      483.10 — Resident Rights
      483.12 — Abuse, Neglect, and Exploitation
      483.15 — Admission, Transfer, and Discharge
      483.24 & 483.25 — Quality of Life & Quality of Care
      483.25 — Trauma Informed Care
      483.30 — Physician Services
      483.35 — Nurse Staffing and Payroll Based Journal
      483.40 — Behavioral Health
      483.45 — Pharmacy Services
      483.60 — Food and Nutrition
      483.70 – Arbitration
      483.75 — Quality Assurance and Performance Improvement
      483.80 — Infection Control
      483.85 — Compliance and Ethics
      483.90 — Physical Environment
      483.95 — Training Requirements
      Psychosocial Outcome Severity Guide
      For a summary of significant changes, see: go.cms/gov/3TvURia.